Gluten Free Diet in Preventing Graft Versus Host Disease in Patients Undergoing Donor Stem Cell Transplant

Rutgers The State University of New Jersey

Status: Terminated

Conditions: Graft Versus Host Disease; Hematopoietic Cell Transplantation Recipient

Treatments: Other: Laboratory Biomarker Analysis; Other: Dietary Intervention

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT03102060

Pro20170000304

NCI-2017-00438 (Registry Identifier)

P30CA072720 (U.S. NIH Grant/Contract)

021701 (Other Identifier)

Details and patient eligibility

About

This pilot clinical trial studies how well a gluten free diet works in preventing graft versus host disease in patients who are undergoing a donor stem cell transplant. Sometimes the transplanted cells from a donor can make an immune response against the body's normal cells (called graft versus host disease). A gluten free diet may decrease intestinal inflammation and graft versus host disease in patients who are undergoing a donor stem cell transplant.

Full description

PRIMARY OBJECTIVES:

I. To determine the rate and severity of gastrointestinal (GI) graft versus host disease (GVHD) in patients assigned to, and compliant with, a gluten free diet (GFD) during initial transplant hospitalization.

SECONDARY OBJECTIVES:

I. To determine the tolerance of, and compliance with, a GFD in patients undergoing allogeneic hematopoietic stem cell transplant (allo-SCT).

OUTLINE:

Patients undergo a gluten free diet for 30 days during initial hospitalization for allo-SCT, from the time of admission to discharge.

After completion of study, patients are followed up at 1, 3, 6, and 12 months.

Enrollment: 7 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Patient undergoing an allo-SCT
• No history of celiac disease or non-celiac gluten sensitivity
• Male and female and all ethnic groups are eligible

Exclusion criteria

• Pregnant women
• Children are not eligible as the transplant program is certified as an adult only transplant program

Trial design

Primary purpose: Prevention

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

---

7 participants in 1 patient group

Prevention (gluten free diet)

Experimental group

Description:

Patients undergo a gluten free diet for 30 days during initial hospitalization for allo-SCT, from the time of admission to discharge.

Treatment:

Other: Laboratory Biomarker Analysis

Other: Dietary Intervention